Glaucoma, Open-AngleNCT05044793
A Clinical Study To Assess The Safety And Effectiveness Of The OMNI® Surgical System
An observational study of Glaucoma, Open-Angle, run by Sight Sciences, Inc. at 4 sites in United States.
Trial summary
The purpose of this study is to evaluate the long-term safety and effectiveness of the OMNI® Surgical System in subjects who were treated under protocol #06213 Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Glaucoma, Open-Angle
- What is being tested?
- OMNI® Surgical System
- Type of treatment
- Medical device
- How many people
- 70 participants
- Where
- 4 sitesUnited States
- Study dates
- 1 Sep 2021to 21 Aug 2023
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Participants who received treatment and completed Protocol #06213
Who may be able to join
- Participated in, received treatment, and completed Protocol #06213
Who cannot join
- Systemic disease that, in the opinion of the Investigator, would put the subject's health at risk and/or prevent completion of required study visits
- Ocular pathology which, in the Investigator's judgment, would either place the subject at increased risk of complications, contraindicate washout, place the subject at risk of significant vision loss during the study period (e.g., wet age macular degeneration (AMD), corneal edema, Fuch's dystrophy, active intraocular infection or inflammation within 30 days prior to Screening Visit, etc.), or interfere with compliance to elements of the study protocol (e.g., returning to Investigator's office for follow-up visits)
Trial locations and contacts
4 sites in 1 country.
United States4 sites
El Paso Eye Surgeons
El Paso, Texas, 79902
Northern Ophthalmics
Jenkintown, Pennsylvania, 19406
Oklahoma Eye Surgeons
Oklahoma City, Oklahoma, 73112
Grene Vision Group
Wichita, Kansas, 62708
About this study
Official title: A Multicenter Clinical Study To Assess The Long-Term Safety And Effectiveness Of The OMNI® Surgical System In Combination With Cataract Surgery In Eyes With Open Angle Glaucoma (GEMINI 2.0)
The purpose of this study is to evaluate the long-term safety and effectiveness of the OMNI® Surgical System in subjects who were treated under protocol #06213
- Conditions
- Glaucoma, Open-Angle
- Being tested
- OMNI® Surgical System
- Medical subject headings
- Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OMNI® Surgical SystemDevice
The OMNI® Surgical System is indicated for canaloplasty (microcatheterization and transluminal viscodilation of Schlemm's canal) followed by trabeculotomy (cutting of trabecular meshwork) to reduce intraocular pressure in adult patients with primary open-angle glaucoma.
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | Subjects who had a surgical washout of ocular hypotensive medications with post-washout DIOP of 21-36mmHg and were treated with OMNI Surgical System for OAG in combination with cataract extraction at least 700 days prior to study enrollment. Receives: Device: OMNI® Surgical System | |
| Cohort B | Subjects without a surgical washout of ocular hypotensive medications with pre-surgical medicated IOP≥18 mmHg and on 1 to 5hypotensive medications and were treated with OMNI Surgical System for OAG in combination with cataract extraction at least 700 days prior to study enrollment. Receives: Device: OMNI® Surgical System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Safety Endpoint
Rate of occurrence of sight-threatening adverse events
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2021
- Study start1 Sep 2021
- Primary completion21 Aug 2023
- Study completion21 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Glaucoma, Open-AngleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sight Sciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05044793
- Sponsor's protocol ID
- 07408
- Status last verified
- Jan 2025
- First submitted
- 9 Sep 2021
- Last updated
- 22 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Clinical Study To Assess The Long-Term Safety And Effectiveness Of The OMNI® Surgical System In Combination With Cataract Surgery In Eyes With Open Angle Glaucoma (GEMINI 2.0)
- ClinicalTrials.gov ID
- NCT05044793
- Acronym / sponsor ID
- 07408
- Conditions
- Glaucoma, Open-Angle
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Sight Sciences, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 21 Aug 2023 (actual)
- Study completion
- 21 Aug 2023 (actual)
- First posted
- 16 Sep 2021 (actual)
- Results
- Posted 22 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the long-term safety and effectiveness of the OMNI® Surgical System in subjects who were treated under protocol #06213
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort A | – | Device: OMNI® Surgical SystemSubjects who had a surgical washout of ocular hypotensive medications with post-washout DIOP of 21-36mmHg and were treated with OMNI Surgical System for OAG in combination with cataract extraction at least 700 days prior to study enrollment. |
| Cohort B | – | Device: OMNI® Surgical SystemSubjects without a surgical washout of ocular hypotensive medications with pre-surgical medicated IOP≥18 mmHg and on 1 to 5hypotensive medications and were treated with OMNI Surgical System for OAG in combination with cataract extraction at least 700 days prior to study enrollment. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants who received treatment and completed Protocol #06213
Key inclusion criteria (1 listed)
- Participated in, received treatment, and completed Protocol #06213
Key exclusion criteria (2 listed)
- Systemic disease that, in the opinion of the Investigator, would put the subject's health at risk and/or prevent completion of required study visits
- Ocular pathology which, in the Investigator's judgment, would either place the subject at increased risk of complications, contraindicate washout, place the subject at risk of significant vision loss during the study period (e.g., wet age macular degeneration (AMD), corneal edema, Fuch's dystrophy, active intraocular infection or inflammation within 30 days prior to Screening Visit, etc.), or interfere with compliance to elements of the study protocol (e.g., returning to Investigator's office for follow-up visits)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OMNI® Surgical SystemThe OMNI® Surgical System is indicated for canaloplasty (microcatheterization and transluminal viscodilation of Schlemm's canal) followed by trabeculotomy (cutting of trabecular meshwork) to reduce intraocular pressure in adult patients with primary open-angle glaucoma. | Device | Cohort A, Cohort B |
Primary outcome
Primary Safety Endpoint
Time frame: 12 months
Rate of occurrence of sight-threatening adverse events
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glaucoma, Open-Angle, run by Sight Sciences, Inc. at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Safety Endpoint (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2025.